As a not-for-profit organization, Partners HealthCare is committed to supporting patient care, research, teaching, and service to the community by leading innovation across our system. Founded by Brigham and Women's Hospital and Massachusetts General Hospital, Partners HealthCare supports a complete continuum of care including community and specialty hospitals, a managed care organization, a physician network, community health centers, home care and other health-related entities. Several of our hospitals are teaching affiliates of Harvard Medical School, and our system is a national leader in biomedical research.
We're focused on a people-first culture for our system's patients and our professional family. That's why we provide our employees with more ways to achieve their potential. Partners HealthCare is committed to aligning our employees' personal aspirations with projects that match their capabilities and creating a culture that empowers our managers to become trusted mentors. We support each member of our team to own their personal development-and we recognize success at every step.
Our employees use the Partners HealthCare values to govern decisions, actions and behaviors. These values guide how we get our work done: Patients, Affordability, Accountability & Service Commitment, Decisiveness, Innovation & Thoughtful Risk; and how we treat each other: Diversity & Inclusion, Integrity & Respect, Learning, Continuous Improvement & Personal Growth, Teamwork & Collaboration.
The Program Management Office, under Partners Innovations, manages a portfolio of industry-sponsored development projects across a number of research groups within the Massachusetts General Hospital (MGH) and Brigham and Woman's Hospital (BWH). These ambitious projects aim to transform clinical medicine through data science, specifically via the use of machine learning and informatics approaches.
Acting under the supervision of the Director of Product and Program Management, the Quality Manager (QM) will support the development of new and existing products, to ensure desired model performance and reliability levels are met in compliance with all applicable regulatory requirements and internal policies and procedures. The Quality Manager will collaborate and coordinate with cross functional projects teams of data scientists, software engineers and clinical experts to create cutting edge clinical software products.
Support the development and manufacturing of medical devices in conformance with quality system standards (ISO 13485, 21 CFR 820) ensuring that internal policies and procedures comply with external regulations and standards
Implement quality management principles on all existing and new industry-sponsored model development projects including developing necessary documentation, assigning team members and ensuring they are educated on the key quality milestones involved in the project
Ensure that quality management principles and practices are followed within all aspects of model development and testing
Perform required reviews, approvals and QA of deviations/change requests throughout the entire model development lifecycle, often acting as an independent evaluator from the core project team
Communicate regularly with a number of stakeholders including core project team members, departmental leadership, industry partners and regulatory officials.
Explain clearly the organization's policies and practices with regards to quality manangement.
Define, implement and monitor quality management standard operating practices (SOPs) within the organization alongside project management personel
Ensure compliance with the Quality Management System (QMS) by training and motivating colleagues in the correct implementation of QMS
Provide guidance, training and education to affiliate labs that are involved in SaMD product development
Drive the development of the QMS system, by collecting feedback from users and industry partners, identifying areas of improvement and reviewing and driving changes to SOPs
Support the definition and implementation of software / IT enablers for the streamlining of quality processes (e.g., audit-trail, data traceability, data access etc.)
Lead audits and inspections
Approve the release and industry transfer of Software as a Medical Device (SaMD) products
Other duties as assigned
Bachelor's degree in engineering, scientific or technical field required; Master's or above preferred
Four or more years of relevant industry experience in managing quality process development, implementation and monitoring with a focus on medical devices or Software as Medical Device (SaMD)
Experience with Quality Management of Medical Devices including knowledge of 21 CFR 820 and ISO 13485 is required
Experience with project management methodologies, concepts and tools including use of project management tracking systems (e.g. Wrike, Confliuence, Jira, MS Project, etc) strongly preferred
Expereince with medical terminology and clinical workflows, including medical imaging diagnostics, pathology, and clinical laboratory medicine preferred
Experience with data science, machine learning, deep learning and database software preferred
Excellent interpersonal skills to effectively communicate with cross functional teams including staff at all levels of the organization including both technical and non-technical personnel
Exceptional problem solving and negotiation skills
Self-motivated, independent and possesses the ability to learn quickly
Ability to successfully negotiate and collaborate with others of different skill sets, backgrounds and levels within and external to the organization
Excellent project management skills (ability to multitask and prioritize work requirements)
Strong sense of urgency and proactiveness - ability to manage and drive work and agenda independently, and source input from manager and team as needed
Strong analytical, planning, organization and time management skills
High attention to detail and understanding of end-to-end processes
Ability to effectively conduct meetings, both formal and informal
Ability to lead and facilitate large working sessions with all levels of staff
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